Quality Analysis of 83 Batches of Compound Jiegeng Mahuangjian Syrup(Ⅱ)from 4 Manufacturers / 中国药房

ABSTRACT

OBJECTIVE:To analyze the results of national evaluation inspection for 83 batches of Compound jiegeng mahuangjian syrup(Ⅱ)from 4 manufacturers,and to evaluate their quality. METHODS:Legal inspection method and exploratory research were adopted to test,analyze and evaluate sample statistically. The contents of exploratory research included HPLC method was used to determine the contents of preservative benzoic acid and ephedrine hydrochloride;antibacterial efficacy examination of formulation was studied;pH value of solution was determined;the content of sucrose was determined by polarimetry photometry;the relationship of the content of ammonium chloride with microbial contamination was studied;headspace GC method was used to determine the contents of menthol and ethanol;Platycodon grandiflorum extractum was identified and studied by TLC. RESULTS:Results of legal inspection showed that among 83 batches of sample,80 batches were qualified and 3 batches were unqualified,with qualified rate of 96.4%. Unqualified items were loading capacity,microbial limit and content ofammonium chloride,content of ammonium chloride. The results of legal test combined with exploratory research showed thatantibacterial efficacy of formulation of one manufacturer was not in accordance with the regulations;Some raw materials were notfed according to formulation, and the quality of products was not even. It is recommended to revise the quality standardidentificatied the Campanulaceae by TLC; determination the pH, preservative content, menthol content; revision ephedrinehydrochloride assay method to HPLC. CONCLUSIONS:The overall quality of Compound jiegeng mahuangjian syrup(Ⅱ)is notsatisfactory;there is a big flaw in the production process and quality control of some manufacturers;quality standards needed to beimproved.